A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis (RESOLUTION-1)

Lilly

Status and phase: Active, not recruiting; Phase 2

Conditions: Joint Diseases; Arthritis; Connective Tissue Diseases; Immune System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Autoimmune Diseases; Rheumatoid Arthritis

Treatments: Drug: Peresolimab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05516758

2022-501425-20-00 (Other Identifier)

J1A-MC-KDAF (Other Identifier)

U1111-1283-9566 (Other Identifier)

18525

Details and patient eligibility

About

The main purpose of this study is to assess the safety and efficacy of peresolimab in adult participants with moderately-to-severely active rheumatoid arthritis.

Enrollment: 491 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a diagnosis of adult onset rheumatoid arthritis (RA) for at least 3 months prior to screening, as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria

• Have moderately-to-severely active RA, at screening and baseline, defined by the presence of

  • ≥6 swollen joints based on 66 joint count, and
  • ≥6 tender joints based on 68 joint count.

• Have had an inadequate response to, or loss of response or intolerance to at least 1 conventional synthetic DMARD (csDMARD), biologic DMARD ( bDMARD), or targeted synthetic DMARD (tsDMARD) treatment.

Exclusion criteria

• Have Class IV RA according to ACR revised criteria.

• Have presence of 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to

  • poorly controlled diabetes or hypertension

  • chronic kidney disease stage IIIb, IV, or V

  • symptomatic heart failure according to New York Heart Association Class II, III, or IV

  • myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, within the past 12 months before randomization

  • severe chronic pulmonary disease, for example, requiring oxygen therapy

  • major chronic inflammatory disease or connective tissue disease other than RA, including but not limited to,

    • systemic lupus erythematosus
    • psoriatic arthritis
    • axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis
    • reactive arthritis
    • gout
    • scleroderma
    • polymyositis
    • dermatomyositis
    • active fibromyalgia, or
    • multiple sclerosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

491 participants in 4 patient groups

Peresolimab Dose 1

Experimental group

Description:

Participants will be given peresolimab by subcutaneous injection.

Treatment:

Drug: Peresolimab

Peresolimab Dose 2

Experimental group

Description:

Participants will be given peresolimab by subcutaneous injection.

Treatment:

Drug: Peresolimab

Peresolimab Dose 3

Experimental group

Description:

Participants will be given peresolimab by subcutaneous injection.

Treatment:

Drug: Peresolimab

Placebo

Active Comparator group

Description:

Participants will be give placebo by subcutaneous injection.

Treatment:

Drug: Placebo